EP2440143B1 - Interspinous implant - Google Patents
Interspinous implant Download PDFInfo
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- EP2440143B1 EP2440143B1 EP10728040.6A EP10728040A EP2440143B1 EP 2440143 B1 EP2440143 B1 EP 2440143B1 EP 10728040 A EP10728040 A EP 10728040A EP 2440143 B1 EP2440143 B1 EP 2440143B1
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- European Patent Office
- Prior art keywords
- wing
- implant
- wings
- orientation
- patient
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
- A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
- A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
- A61B17/70—Spinal positioners or stabilisers ; Bone stabilisers comprising fluid filler in an implant
- A61B17/7062—Devices acting on, attached to, or simulating the effect of, vertebral processes, vertebral facets or ribs ; Tools for such devices
- A61B17/7065—Devices with changeable shape, e.g. collapsible or having retractable arms to aid implantation; Tools therefor
Definitions
- the invention relates generally to the treatment of spinal conditions, and more particularly, to the treatment of spinal conditions using an implant configured for insertion into an interspinous space.
- the implant is adjustable between a closed orientation with a reduced size to facilitate insertion into the patient and a deployed orientation with an enlarged size to maintain the position within the patient.
- a significant portion of the population will experience back pain at some point in their lives resulting from a spinal condition.
- the pain may range from general discomfort to disabling pain that immobilizes the individual.
- Back pain may result from a trauma to the spine, be caused by the natural aging process, or may be the result of a degenerative disease or condition.
- Procedures to remedy back problems sometimes require correcting the distance. between vertebral members by inserting an interspinous device (e.g., spacer) between spinous processes.
- an interspinous device e.g., spacer
- implants are positioned between the spinous processes of the L5 and S1 vertebral members.
- current implants often cannot be used in this space because of the huge variations in the sacral anatomy and the lack of an S1 spinous process in about 70% of the population.
- an interspinous implant often requires extensive surgical techniques. These implants often require an open technique to be implanted, and many require destroying important anatomical stabilizers, such as the supraspinous ligament. In particular, some techniques for placing such implants is to cut the interspinous and supraspinous ligaments and slide the device over the adjacent spinous processes. Therefore, there is a need for an implant that can be positioned in the interspinous space, and also can be implanted in a less intrusive manner.
- US 2008/108990 A1 discloses an interspinous implant adapted to be inserted between spinous processes.
- the implant comprises a first wing, a spacer extending from the first wing, a distraction guide and a second wing extending from the spacer.
- the second wing has a first configuration and is selectably arrangeable in a second configuration. In the first configuration the second wing has a height that is approximately the same as the thickness of the spacer. In the second configuration the second wing has a height that is greater than the thickness of the spacer.
- a hole extends through the spacer and the first wing.
- a rod is disposed within the hole and is used to selectably arrange the second wing to the first configuration and the second configuration when moved relative to the spacer.
- the second wing is pivotably connected between the distraction guide and the spacer.
- US 2008/114456 A1 discloses an interspinous spacer system.
- a core has a shape configured to fit in an interspinous space between adjacent spinous processes.
- a plurality of extending forks extends from the core and are shaped to extend along vertical sides of the spinous processes.
- a first fork of the plurality of forks is moveable relative to the core from a non-use position to an in-use position.
- the first fork is located on a first side of the core in the in-use position and has a first inner side defining an opening for receiving a first spinous process of the spinous processes.
- the first fork is substantially non-flexible.
- a second fork is located on the first side of the core and has a second inner side defining an opening for receiving the first spinous process of the spinous processes.
- the second fork is immovable relative to the core.
- the first fork avoids protruding from the core such that the first fork bounds the opening in the non-use position to allow the core to be inserted into the interspinous space.
- US 2006/224241 A1 discloses an expandable vertebral body device for insertion into a spinal (intervertebral or intravertebral) space.
- the device provides controlled, vertical expansion within the intervertebral space as well as vertical retraction within the intervertebral space.
- the device includes identical end plates each having holes or bores.
- a central axis or shaft has ends retained in each end plate for rotation of the shaft. The ends of the shaft are configured to receive a tool for rotation of the shaft and the expansion or retraction of a plurality of plates.
- the plates are connected to the shaft such that one set of plates move in one outward direction (expansion) upon shaft rotation in a first direction while another set of plates move in another (opposite) outward direction (expansion) upon shaft rotation in the first direction.
- Shaft rotation in a second direction causes both sets of plates to retract. The adjustment of the expansion/retraction of the plates is done in situ.
- the present application is directed to implants for insertion into the interspinous space formed between first and second vertebral members.
- the implants include a main body and a pair of wings that extend outward from the body.
- the implants are sized and configured for the main body to be positioned along a centerline of the spine with the wings on opposing lateral sides of a spinous process of the first vertebral member.
- the body may contact or may be spaced from the second vertebral member.
- the implants may further be selectively adjustable between a collapsed orientation-and an extended orientation.
- the collapsed orientation features one or both wings aligned in proximity with the main body to reduce an overall size of the implant to facilitate insertion into the patient.
- the extended orientation includes the wings extending outward from the body for positioning against the first spinous process.
- the implants may include various configurations of bodies and wings.
- Figures 1-3 illustrate an implant 10 with a body 20, first and second wings 30, and a deployment mechanism 60.
- the body 20 includes an elongated shape with a first end 21 and a second end 22.
- the body 20 also includes a first section 25 at the first end 21 that may include a tapered shape that facilitates insertion of the implant 10 into the patient.
- the first section 25 may include various cross-sectional shapes. In one embodiment, the first section 25 is not tapered.
- the first end 21 may be substantially flat, or may include a point.
- the body 20 also includes a second section 26.
- the second section 26 is cylindrical, although it may also include various other cross-sectional shapes, including but not limited to elliptical and oblong
- the first section 25 may be sized to increase in cross-sectional size and provide a smooth transition to the second section 26.
- Recesses 23, 24 are positioned in the body 20 to receive the wings 30.
- the illustrated embodiment includes each of the recesses 23, 24 positioned along the second section 26.
- the first recess 23 is positioned at a first end of the second section 26 and is positioned at the transition with the first section 25, and the second recess 24 extends into the second section 26 from the second end 22.
- the recesses 23, 24 may extend completely through the body 20, or may extend a limited depth inward from the superior surface.
- a slot 28 extends through the body 20 between the recesses 23, 24.
- the slot 28 is positioned within an interior of the body 20 under the exterior surface of the gap 27.
- the wings 30 are sized to fit within the recesses 23, 24.
- the wings 30 include a first end 31 and a second end 32.
- One or both ends 31, 32 may include a rounded shape that corresponds to the rounded exterior surface of the body 20.
- the wings 30 may be substantially identical, or may include different shapes, sizes, and features.
- Wings 30 may also include teeth 33 that extend laterally outward from an inner side.
- the teeth 33 are configured to engage with the spinous process of the first vertebral member and may include various shapes and sizes.
- the embodiments of Figure 1-3 include teeth 33 on each of the wings 30, although teeth 33 may be included on just one of the wings 30.
- the teeth 33 may include various shapes other than those illustrated, including but not limited to ridges and knurled sections.
- the teeth 33 on the first wing 30 are offset from the teeth 33 on the second wing 30. The offset positioning prevents the teeth from contacting together when the wings 30 are engaged with the spinous process.
- the deployment mechanism 60 moves the wings 30 between the closed orientation as illustrated in Figure 3 and the deployed orientation as illustrated in Figure 1 .
- the deployment mechanism 60 may also laterally move the wings 30 relative to each other for attachment to the spinous process of the superior vertebral member.
- Figure 2 illustrates a deployment mechanism 60 that includes a rod 61 and a fastener 62.
- the rod 61 includes an elongated shape with a threaded section 63.
- the rod 61 is attached to the first wing 30 and includes a length to extend through the slot 28 and at least into the opposing recess 24.
- the rod 61 is sized to fit through an aperture 34 in the second wing 30 with the threaded section 63 at least partially extending outward from the second wing 30.
- the fastener 62 is threaded onto the threaded section 63.
- Fastener 62 may be a nut that attaches to the rod 61.
- the rod 61 may include one or more weakened sections, including a reduced cross-sectional size.
- the weakened sections are positioned along the section that extends outward beyond the fastener 62.
- the surgeon can apply a force to the appropriate section to reduce the length of the rod 61.
- the weakened sections are positioned such that the rod 61 does not extend outward beyond the body 20.
- Figure 4A includes a front view of the implant 10 in the closed orientation with both wings 30 closed into the body 20.
- the first section 25 includes a tapered shape with a maximum diameter greater than or equal to the diameter of the second section 26. Therefore, the second section 26 is not visible in this front view. This reduced size in the closed orientation facilitates insertion into the patient and adjacent to the spinous process.
- Figure 4B illustrates the implant 10 in the deployed orientation with the wings 30 extending outward beyond the envelope of the body 20.
- Figures 5A-5C illustrate positioning and deployment of the implant 10 within the interspinous space 120 formed between the vertebral members 100,200.
- the first vertebral member 100 is an L5 vertebral member
- the second vertebral member 200 is a sacrum that does not include a spinous process adequate to support and/or position the implant 10.
- the implant 10 is positioned on the sacral roof of the sacrum.
- the implant 10 includes a reduced size in the closed orientation as illustrated in Figure 5A that facilitates insertion into the patient.
- the implant 10 may be inserted percutaneously with the use of the proper tools.
- the implant 10 may also be inserted through a mini-open incision that requires unilateral tissue retraction as the wings 30 are both deployed from the ipsilateral side as will be explained below.
- This sequence includes the fastener 62 attached to the rod 61 to connect the wings 30 together prior to insertion into the patient.
- the rod 61 is attached to the wings 30 after insertion of the body 20 and wings 30 into the patient.
- Figure 5A includes the implant 10 positioned within the patient with the body 20 resting against the roof ( i.e., superior edge) of the second vertebral member 200 which in this embodiment is the sacrum.
- the body 20 does not contact the second vertebral member 200:
- the body 20 may include a height measured between superior and inferior surfaces of the second section 26 for the gap 27 on the first surface to contact the inferior edge of the spinous process of the first vertebral member 100 while the inferior surface contacts against the second vertebral member 200.
- the reduced size of the implant 10 in the closed orientation with the wings 30 positioned within the profile of the body 20 facilitates insertion into the patient.
- the conical first section 25 is shaped to ease the insertion into the space 120.
- the wings 30 are enclosed within the body 20 to allow for smooth dilation and insertion through the interspinous space 120. In some instances, the wings 30 may not completely fit within the recesses 23, 24 resulting in the second ends 32 extending beyond the superior surface of the second section 26.
- Figure 5A includes the first section 25 including a larger size than the second section 26 (i.e., a larger profile). Thus, even though the second ends 32 extend outward beyond the second section 26, the wings 30 are still positioned within the profile of the first section 25.
- Figure 5B includes the implant 10 in a partially deployed orientation. Deployment occurs with the surgeon applying a force in a superior direction on the fastener 62 which is exposed at the second end 22 of the body 20 through the insertion path. This force causes the fastener 62, rod 61 and attached wings 30 to move upward relative to the body 20 and the rod 61 to move along the slot 28 in the body 20.
- the length of the rod 61 causes the wings 30 to be spaced apart a distance to extend outward from the body 20 along each lateral side of the spinous process 100. This spacing allows for the deploying movement without the wings 30 contacting against the spinous process 100.
- the extent of deployment of the wings 30 from the body 20 may vary depending upon the context of use. Full deployment occurs when the rod 61 contacts against an upper edge of the slot 28 thereby preventing further deployment movement.
- the body 20 and one or both wings 30 include a ratchet structure. This may include a stepped or wedged shape on each of the body 20 and wings 30. During deployment, the wings 30 move outward from the body 20 and along the ratchet structure.
- the wings 30 deploy in a stepped process and may be positioned at the various steps to extend outward from the body 30 the desired amount.
- the fastener 62 is further threaded onto the threaded section 63 of the rod 61.
- the threading causes the fastener 62 to move along the length of the rod 61 and force the wings 30 together. This may include movement of both wings 30 relative to the body 20, or movement of just one wing 30 with the other wing remaining stationary relative to the body 20. In one embodiment, just the proximal wing 30 moves with the distal wing 30 remaining stationary. This movement results in the teeth 33 contacting with the spinous process 100 to attach the implant 10.
- the extent of inward movement of the wings 30 may vary depending upon the context. As illustrated in Figure 5C , the fastener 62 may move along the rod 61 and beyond the second end 22 of the body 20 and into the recess 24. This portion of the rod 61 may be removed by the surgeon once the implant 10 is properly positioned in the patient.
- the implant 10 may also include one or more pins to maintain the position of the wings 30. Apertures in the wings 30 and body 20 are sized to receive the pins to secure the relative positions. In one embodiment, a wedge is inserted into the slot 28 after the wings 30 are deployed. The wedge prevents the rod 61 from moving within the slot 28 and possibly causing the wings 20 to retract.
- both wings 30 are retracted in to the body 30 with the implant 10 in the closed orientation.
- just the first or leading wing 30 adjacent to the first section 25 retracts into the body 20.
- the second or trailing wing 30 adjacent to the second end 22 may not retract into the body 20 because this second wing 30 does not pass through the interspinous space 120 during the implantation process.
- the body 20 may be wrapped in cushioning outer sleeve or coated with a compliant material.
- the body 20 may also be comprised of materials that are closer in stiffness to the first and second vertebral members 100, 200 to prevent subsidence of the implant 10. This is important in embodiments in which the body 20 contacts the sacrum, and especially for contact with the sacrum lamina which are relatively weak. These materials may have a Modulus of Elasticity (MOE) that is particularly matched with the vertebral members 100, 200. According to one particular embodiment, the difference of the MOE of the material and the vertebral members 10, 200 is not greater than about 30 GPa.
- MOE Modulus of Elasticity
- the difference is less, such as not greater than about 15 GPa, not greater than about 5 GPA, or not greater than about 1 GPa.
- compliant material include but are not limited to silicone, polyaryletheretherketone (PEEK), polyeurathane, and rubber.
- the material may be positioned to facilitate placement of the body 20 within the interspinous space.
- Figure 6 includes a schematic side view of the body 20 positioned within the interspinous space 120 with material 290 on the superior and inferior sides illustrated in cross section. The wing has been removed from the implant 10 in Figure 6 to facilitate viewing of the body 20.
- the body 20 includes a core 295 with material 290 positioned on the superior and inferior sides. Positioning of the material 290 at these sides facilitates placement of the implant 10 as anterior as possible.
- the core 295 may be solid or hollow.
- the material 290 may be placed on one or both of the inferior and superior sides.
- the implants 10 may be implanted within a living patient for the treatment of various spinal disorders.
- the implant 10 may also be implanted in a non-living situation, such as within a cadaver, model, and the like.
- the non-living situation may be for one or more of testing, training, and demonstration purposes.
- the implant 10 may be positioned in the patient with the wings 30 extending superiorly outward to contact against the spinous process of the superior vertebral member 100.
- the implant 10 may also be positioned in an opposite orientation (i.e., rotated 180 degrees) with the wings 30 extending inferiorly outward and contacting against a spinous process of the inferior vertebral member 200.
- teeth may be positioned on the wings to engage with spinous processes.
- the teeth may include various shapes, sizes, and placements. In some embodiments, one or both of the wings do not include teeth.
- the wings 30 contact against a spinous process of a first. vertebral member 100, and the body 20 contacts against the second vertebral member.
- the implant 10 may also be positioned in the patient with the body 20 spaced away from the second vertebral member such that there is no contact.
- the implant 10 is inserted into the space 120 and contacts against one or more of the first and second vertebral members 100,200. This contact may include direct contact with these members, and also indirect contact with the implant 10 directly contacting the surrounding ligaments and tissue. In both instances, the implant 10 includes a similar effectiveness for treating the spinal disorder for which it was implanted.
- the implants 10 may be used in the interspinous space 120 formed between the L5 vertebra and sacrum.
- the implants 10 may also be positioned at other locations along the spine for spacing apart the vertebral members. Applications may also place the implant at other regions of the spine, including the cervical, thoracic, and lumbar regions.
- distal is generally defined as in the direction of the patient, or away from a user of a device. Conversely, “proximal” generally means away from the patient, or toward the user.
- Spatially relative terms such as “under”, “below”, “lower”, “over”, “upper”, and the like, are used for ease of description to explain the positioning of one element relative to a second element. These terms are intended to encompass different orientations of the device in addition to different orientations than those depicted in the figures. Further, terms such as “first”, “second”, and the like, are also used to describe various elements, regions, sections, etc and are also not intended to be limiting. Like terms refer to like elements throughout the description.
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Description
- The invention relates generally to the treatment of spinal conditions, and more particularly, to the treatment of spinal conditions using an implant configured for insertion into an interspinous space. The implant is adjustable between a closed orientation with a reduced size to facilitate insertion into the patient and a deployed orientation with an enlarged size to maintain the position within the patient.
- A significant portion of the population will experience back pain at some point in their lives resulting from a spinal condition. The pain may range from general discomfort to disabling pain that immobilizes the individual. Back pain may result from a trauma to the spine, be caused by the natural aging process, or may be the result of a degenerative disease or condition.
- Procedures to remedy back problems sometimes require correcting the distance. between vertebral members by inserting an interspinous device (e.g., spacer) between spinous processes. In some instances, implants are positioned between the spinous processes of the L5 and S1 vertebral members. However, current implants often cannot be used in this space because of the huge variations in the sacral anatomy and the lack of an S1 spinous process in about 70% of the population.
- Further, insertion of an interspinous implant often requires extensive surgical techniques. These implants often require an open technique to be implanted, and many require destroying important anatomical stabilizers, such as the supraspinous ligament. In particular, some techniques for placing such implants is to cut the interspinous and supraspinous ligaments and slide the device over the adjacent spinous processes. Therefore, there is a need for an implant that can be positioned in the interspinous space, and also can be implanted in a less intrusive manner.
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US 2008/108990 A1 discloses an interspinous implant adapted to be inserted between spinous processes. The implant comprises a first wing, a spacer extending from the first wing, a distraction guide and a second wing extending from the spacer. The second wing has a first configuration and is selectably arrangeable in a second configuration. In the first configuration the second wing has a height that is approximately the same as the thickness of the spacer. In the second configuration the second wing has a height that is greater than the thickness of the spacer. A hole extends through the spacer and the first wing. A rod is disposed within the hole and is used to selectably arrange the second wing to the first configuration and the second configuration when moved relative to the spacer. The second wing is pivotably connected between the distraction guide and the spacer. -
US 2008/114456 A1 discloses an interspinous spacer system. A core has a shape configured to fit in an interspinous space between adjacent spinous processes. A plurality of extending forks extends from the core and are shaped to extend along vertical sides of the spinous processes. A first fork of the plurality of forks is moveable relative to the core from a non-use position to an in-use position. The first fork is located on a first side of the core in the in-use position and has a first inner side defining an opening for receiving a first spinous process of the spinous processes. The first fork is substantially non-flexible. A second fork is located on the first side of the core and has a second inner side defining an opening for receiving the first spinous process of the spinous processes. The second fork is immovable relative to the core. The first fork avoids protruding from the core such that the first fork bounds the opening in the non-use position to allow the core to be inserted into the interspinous space. -
US 2006/224241 A1 discloses an expandable vertebral body device for insertion into a spinal (intervertebral or intravertebral) space. The device provides controlled, vertical expansion within the intervertebral space as well as vertical retraction within the intervertebral space. The device includes identical end plates each having holes or bores. A central axis or shaft has ends retained in each end plate for rotation of the shaft. The ends of the shaft are configured to receive a tool for rotation of the shaft and the expansion or retraction of a plurality of plates. The plates are connected to the shaft such that one set of plates move in one outward direction (expansion) upon shaft rotation in a first direction while another set of plates move in another (opposite) outward direction (expansion) upon shaft rotation in the first direction. Shaft rotation in a second direction causes both sets of plates to retract. The adjustment of the expansion/retraction of the plates is done in situ. - According to the present invention there is provided the implant of claim 1.
- Additional possible aspects for the implant are set out in the dependent claims.
- An embodiment of apparatus in accordance with the present invention will now be described, by way of example only, with reference to the accompanying drawings.
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Figure 1 is a perspective view of an implant in a deployed orientation according to one embodiment. -
Figure 2 is an exploded perspective view of an implant according to one embodiment. -
Figure 3 is a perspective view of an implant in a closed orientation according to one embodiment. -
Figure 4A is a front view of an implant in a closed orientation according to one embodiment. -
Figure 4B is a front view of an implant in a deployed orientation according to one embodiment. -
Figure 5A is a side view of an implant in a closed orientation inserted within a patient according to one embodiment. -
Figure 5B is a side view of an implant in a partially deployed orientation inserted within a patient according to one embodiment. -
Figure 5C is a side view of an implant in a deployed orientation inserted within a patient according to one embodiment. -
Figure 6 is a schematic cross section of a body positioned within an interspinous space according to one embodiment. - The present application is directed to implants for insertion into the interspinous space formed between first and second vertebral members. The implants include a main body and a pair of wings that extend outward from the body. The implants are sized and configured for the main body to be positioned along a centerline of the spine with the wings on opposing lateral sides of a spinous process of the first vertebral member. The body may contact or may be spaced from the second vertebral member. The implants may further be selectively adjustable between a collapsed orientation-and an extended orientation. The collapsed orientation features one or both wings aligned in proximity with the main body to reduce an overall size of the implant to facilitate insertion into the patient. The extended orientation includes the wings extending outward from the body for positioning against the first spinous process.
- The implants may include various configurations of bodies and wings.
Figures 1-3 illustrate animplant 10 with abody 20, first andsecond wings 30, and adeployment mechanism 60. Thebody 20 includes an elongated shape with afirst end 21 and asecond end 22. Thebody 20 also includes afirst section 25 at thefirst end 21 that may include a tapered shape that facilitates insertion of theimplant 10 into the patient. Thefirst section 25 may include various cross-sectional shapes. In one embodiment, thefirst section 25 is not tapered. Thefirst end 21 may be substantially flat, or may include a point. Thebody 20 also includes asecond section 26. In the embodiment ofFigures 1-3 , thesecond section 26 is cylindrical, although it may also include various other cross-sectional shapes, including but not limited to elliptical and oblong Thefirst section 25 may be sized to increase in cross-sectional size and provide a smooth transition to thesecond section 26. -
Recesses body 20 to receive thewings 30. Therecesses 23, 24-are spaced apart by agap 27 sized to accommodate the first spinous process. The illustrated embodiment includes each of therecesses second section 26. Thefirst recess 23 is positioned at a first end of thesecond section 26 and is positioned at the transition with thefirst section 25, and thesecond recess 24 extends into thesecond section 26 from thesecond end 22. Therecesses body 20, or may extend a limited depth inward from the superior surface. - As illustrated in
Figure 2 , aslot 28 extends through thebody 20 between therecesses slot 28 is positioned within an interior of thebody 20 under the exterior surface of thegap 27. - The
wings 30 are sized to fit within therecesses wings 30 include afirst end 31 and asecond end 32. One or both ends 31, 32 may include a rounded shape that corresponds to the rounded exterior surface of thebody 20. Thewings 30 may be substantially identical, or may include different shapes, sizes, and features.Wings 30 may also includeteeth 33 that extend laterally outward from an inner side. Theteeth 33 are configured to engage with the spinous process of the first vertebral member and may include various shapes and sizes. The embodiments ofFigure 1-3 includeteeth 33 on each of thewings 30, althoughteeth 33 may be included on just one of thewings 30. Theteeth 33 may include various shapes other than those illustrated, including but not limited to ridges and knurled sections. In one embodiment, theteeth 33 on thefirst wing 30 are offset from theteeth 33 on thesecond wing 30. The offset positioning prevents the teeth from contacting together when thewings 30 are engaged with the spinous process. - The
deployment mechanism 60 moves thewings 30 between the closed orientation as illustrated inFigure 3 and the deployed orientation as illustrated inFigure 1 . Thedeployment mechanism 60 may also laterally move thewings 30 relative to each other for attachment to the spinous process of the superior vertebral member. -
Figure 2 illustrates adeployment mechanism 60 that includes arod 61 and afastener 62. Therod 61 includes an elongated shape with a threadedsection 63. Therod 61 is attached to thefirst wing 30 and includes a length to extend through theslot 28 and at least into the opposingrecess 24. Therod 61 is sized to fit through anaperture 34 in thesecond wing 30 with the threadedsection 63 at least partially extending outward from thesecond wing 30. Thefastener 62 is threaded onto the threadedsection 63.Fastener 62 may be a nut that attaches to therod 61. Therod 61 may include one or more weakened sections, including a reduced cross-sectional size. The weakened sections are positioned along the section that extends outward beyond thefastener 62. The surgeon can apply a force to the appropriate section to reduce the length of therod 61. In one-embodiment; the weakened sections are positioned such that therod 61 does not extend outward beyond thebody 20. - In the closed orientation, at least the leading
wing 30 adjacent to thefirst section 25 is positioned within the profile formed by the-body 20.Figure 4A includes a front view of theimplant 10 in the closed orientation with bothwings 30 closed into thebody 20. In this embodiment, thefirst section 25 includes a tapered shape with a maximum diameter greater than or equal to the diameter of thesecond section 26. Therefore, thesecond section 26 is not visible in this front view. This reduced size in the closed orientation facilitates insertion into the patient and adjacent to the spinous process.Figure 4B illustrates theimplant 10 in the deployed orientation with thewings 30 extending outward beyond the envelope of thebody 20. -
Figures 5A-5C illustrate positioning and deployment of theimplant 10 within theinterspinous space 120 formed between the vertebral members 100,200. In this embodiment, the firstvertebral member 100 is an L5 vertebral member, and the secondvertebral member 200 is a sacrum that does not include a spinous process adequate to support and/or position theimplant 10. Theimplant 10 is positioned on the sacral roof of the sacrum. - The
implant 10 includes a reduced size in the closed orientation as illustrated inFigure 5A that facilitates insertion into the patient. Theimplant 10 may be inserted percutaneously with the use of the proper tools. Theimplant 10 may also be inserted through a mini-open incision that requires unilateral tissue retraction as thewings 30 are both deployed from the ipsilateral side as will be explained below. This sequence includes thefastener 62 attached to therod 61 to connect thewings 30 together prior to insertion into the patient. In other embodiments, therod 61 is attached to thewings 30 after insertion of thebody 20 andwings 30 into the patient. -
Figure 5A includes theimplant 10 positioned within the patient with thebody 20 resting against the roof ( i.e., superior edge) of the secondvertebral member 200 which in this embodiment is the sacrum. In other embodiments, thebody 20 does not contact the second vertebral member 200: Thebody 20 may include a height measured between superior and inferior surfaces of thesecond section 26 for thegap 27 on the first surface to contact the inferior edge of the spinous process of the firstvertebral member 100 while the inferior surface contacts against the secondvertebral member 200. The reduced size of theimplant 10 in the closed orientation with thewings 30 positioned within the profile of thebody 20 facilitates insertion into the patient. The conicalfirst section 25 is shaped to ease the insertion into thespace 120. - The
wings 30 are enclosed within thebody 20 to allow for smooth dilation and insertion through theinterspinous space 120. In some instances, thewings 30 may not completely fit within therecesses second section 26.Figure 5A includes thefirst section 25 including a larger size than the second section 26 (i.e., a larger profile). Thus, even though the second ends 32 extend outward beyond thesecond section 26, thewings 30 are still positioned within the profile of thefirst section 25. -
Figure 5B includes theimplant 10 in a partially deployed orientation. Deployment occurs with the surgeon applying a force in a superior direction on thefastener 62 which is exposed at thesecond end 22 of thebody 20 through the insertion path. This force causes thefastener 62,rod 61 and attachedwings 30 to move upward relative to thebody 20 and therod 61 to move along theslot 28 in thebody 20. - The length of the
rod 61 causes thewings 30 to be spaced apart a distance to extend outward from thebody 20 along each lateral side of thespinous process 100. This spacing allows for the deploying movement without thewings 30 contacting against thespinous process 100. The extent of deployment of thewings 30 from thebody 20 may vary depending upon the context of use. Full deployment occurs when therod 61 contacts against an upper edge of theslot 28 thereby preventing further deployment movement. In one embodiment, thebody 20 and one or bothwings 30 include a ratchet structure. This may include a stepped or wedged shape on each of thebody 20 andwings 30. During deployment, thewings 30 move outward from thebody 20 and along the ratchet structure. Thewings 30 deploy in a stepped process and may be positioned at the various steps to extend outward from thebody 30 the desired amount. - Once at the proper position, the
fastener 62 is further threaded onto the threadedsection 63 of therod 61. The threading causes thefastener 62 to move along the length of therod 61 and force thewings 30 together. This may include movement of bothwings 30 relative to thebody 20, or movement of just onewing 30 with the other wing remaining stationary relative to thebody 20. In one embodiment, just theproximal wing 30 moves with thedistal wing 30 remaining stationary. This movement results in theteeth 33 contacting with thespinous process 100 to attach theimplant 10. The extent of inward movement of thewings 30 may vary depending upon the context. As illustrated inFigure 5C , thefastener 62 may move along therod 61 and beyond thesecond end 22 of thebody 20 and into therecess 24. This portion of therod 61 may be removed by the surgeon once theimplant 10 is properly positioned in the patient. - The
implant 10 may also include one or more pins to maintain the position of thewings 30. Apertures in thewings 30 andbody 20 are sized to receive the pins to secure the relative positions. In one embodiment, a wedge is inserted into theslot 28 after thewings 30 are deployed. The wedge prevents therod 61 from moving within theslot 28 and possibly causing thewings 20 to retract. - In the embodiment described above, both
wings 30 are retracted in to thebody 30 with theimplant 10 in the closed orientation. Alternatively, just the first or leadingwing 30 adjacent to thefirst section 25 retracts into thebody 20. The second or trailingwing 30 adjacent to thesecond end 22 may not retract into thebody 20 because thissecond wing 30 does not pass through theinterspinous space 120 during the implantation process. - The
body 20 may be wrapped in cushioning outer sleeve or coated with a compliant material. Thebody 20 may also be comprised of materials that are closer in stiffness to the first and secondvertebral members implant 10. This is important in embodiments in which thebody 20 contacts the sacrum, and especially for contact with the sacrum lamina which are relatively weak. These materials may have a Modulus of Elasticity (MOE) that is particularly matched with thevertebral members vertebral members - The material may be positioned to facilitate placement of the
body 20 within the interspinous space.Figure 6 includes a schematic side view of thebody 20 positioned within theinterspinous space 120 withmaterial 290 on the superior and inferior sides illustrated in cross section. The wing has been removed from theimplant 10 inFigure 6 to facilitate viewing of thebody 20. Thebody 20 includes a core 295 withmaterial 290 positioned on the superior and inferior sides. Positioning of the material 290 at these sides facilitates placement of theimplant 10 as anterior as possible. Thecore 295 may be solid or hollow. Thematerial 290 may be placed on one or both of the inferior and superior sides. - The
implants 10 may be implanted within a living patient for the treatment of various spinal disorders. Theimplant 10 may also be implanted in a non-living situation, such as within a cadaver, model, and the like. The non-living situation may be for one or more of testing, training, and demonstration purposes. - In various embodiments, the
implant 10 may be positioned in the patient with thewings 30 extending superiorly outward to contact against the spinous process of the superiorvertebral member 100. Theimplant 10 may also be positioned in an opposite orientation (i.e., rotated 180 degrees) with thewings 30 extending inferiorly outward and contacting against a spinous process of the inferiorvertebral member 200. - In the various embodiments, teeth may be positioned on the wings to engage with spinous processes. The teeth may include various shapes, sizes, and placements. In some embodiments, one or both of the wings do not include teeth.
- In some embodiment, the
wings 30 contact against a spinous process of a first.vertebral member 100, and thebody 20 contacts against the second vertebral member. - The
implant 10 may also be positioned in the patient with thebody 20 spaced away from the second vertebral member such that there is no contact. - The
implant 10 is inserted into thespace 120 and contacts against one or more of the first and second vertebral members 100,200. This contact may include direct contact with these members, and also indirect contact with theimplant 10 directly contacting the surrounding ligaments and tissue. In both instances, theimplant 10 includes a similar effectiveness for treating the spinal disorder for which it was implanted. - The
implants 10 may be used in theinterspinous space 120 formed between the L5 vertebra and sacrum. Theimplants 10 may also be positioned at other locations along the spine for spacing apart the vertebral members. Applications may also place the implant at other regions of the spine, including the cervical, thoracic, and lumbar regions. - The term "distal" is generally defined as in the direction of the patient, or away from a user of a device. Conversely, "proximal" generally means away from the patient, or toward the user. Spatially relative terms such as "under", "below", "lower", "over", "upper", and the like, are used for ease of description to explain the positioning of one element relative to a second element. These terms are intended to encompass different orientations of the device in addition to different orientations than those depicted in the figures. Further, terms such as "first", "second", and the like, are also used to describe various elements, regions, sections, etc and are also not intended to be limiting. Like terms refer to like elements throughout the description.
- As used herein, the terms "having", "containing", "including", "comprising" and the like are open ended terms that indicate the presence of stated elements or features, but do not preclude additional elements or features. The articles "a", "an" and "the" are intended to include the plural as-well as the singular, unless the context clearly indicates otherwise.
- The present invention may be carried out in other specific ways than those herein set forth without departing from the scope and essential characteristics of the invention. The present embodiments are, therefore, to be considered in all respects as illustrative and not restrictive, and all changes coming within the meaning and equivalency range of the appended claims are intended to be embraced therein.
Claims (8)
- An implant (10) for insertion into an interspinous space between first and second vertebral members of a patient, the implant comprising:a body (20) including a leading end (21) and a trailing end (22) and sized to fit within the interspinous space, the body further including a first side that faces towards the first vertebral member and a second side that faces towards the second vertebral member when the implant is inserted into the patient;a first wing (30) positioned in proximity to the leading end and away from the trailing end, the first wing movably connected to the body and selectively positionable from a closed orientation positioned at the first side of the body to a deployed orientation extending outward beyond the first side of the body;a second wing (30) positioned in proximity to the trailing end and away from the leading end, the second wing extending outward beyond the first side of the body when the first wing is in the deployed orientation;a deploying mechanism (60) operatively connected to the first wing and the second wing, the deploying mechanism configured to move the first wing from the closed orientation to the deployed orientation, the deploying mechanism also configured to move at least one of the first wing away from the leading end and the second wing away from the trailing end to move the wings into contact with a spinous process of the first vertebral member when the implant is positioned in the patient;each of the first and second wings positioned vertically inward from the second side of the body when the first wing is in the deployed orientation to prevent the first and second wings from contacting against the second vertebral member when the body is in contact with the second vertebral member.
- The implant of claim 1, wherein the second side of the body (20) includes a compliant material (290) that contacts against the second vertebral member when the implant is positioned in the patient.
- The implant of claim 1, wherein the second wing (30) is fixed relative to the body (20) and extends outward above the first side of the body when the first wing (30) is in both the closed and deployed orientations.
- The implant of claim 1, wherein the deploying mechanism (60) includes a rod (61) that includes a first end connected to the first wing (31) and a second end positioned on an exterior of the second wing (30) away from the first wing, the rod further extending through the body (20) and the second wing, the rod connected to the first wing away from midpoint of the height of the first wing.
- The implant of claim 4, wherein the rod (61) is rotatably positioned within the second wing (30) and the body (20) to rotate the first wing from the closed orientation to the open orientation.
- The implant of claim 1, wherein the body (20) includes first and second apertures with the first aperture (52) aligned to receive teeth (33) that extend outward from the first and second wings (30) when the first wing is in the closed orientation and the second aperture (51) receives a rod (61) that extends through the body (20) and the second wing (30).
- The implant of claim 1, wherein the first wing (30) includes a tapered body with a cross-sectional size that increases from the leading end (21) towards an inner end of the first wing, with the inner end in contact against the body (20) when the first wing is in the closed orientation.
- The implant of claim 1, wherein the first wing (30) is positioned vertically below the first side of the body (20) in the closed orientation and implanted in the patient.
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US12/483,812 US8157842B2 (en) | 2009-06-12 | 2009-06-12 | Interspinous implant and methods of use |
PCT/US2010/037353 WO2010144309A1 (en) | 2009-06-12 | 2010-06-04 | Interspinous implant and methods of use |
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EP2440143A1 EP2440143A1 (en) | 2012-04-18 |
EP2440143B1 true EP2440143B1 (en) | 2015-05-27 |
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EP (1) | EP2440143B1 (en) |
CN (1) | CN102802546B (en) |
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-
2009
- 2009-06-12 US US12/483,812 patent/US8157842B2/en active Active
-
2010
- 2010-06-04 WO PCT/US2010/037353 patent/WO2010144309A1/en active Application Filing
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- 2010-06-04 EP EP10728040.6A patent/EP2440143B1/en active Active
- 2010-06-04 CN CN201080035842.0A patent/CN102802546B/en not_active Expired - Fee Related
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EP2440143A1 (en) | 2012-04-18 |
CN102802546B (en) | 2015-02-04 |
US8157842B2 (en) | 2012-04-17 |
US20100318127A1 (en) | 2010-12-16 |
CN102802546A (en) | 2012-11-28 |
WO2010144309A1 (en) | 2010-12-16 |
AU2010259067A1 (en) | 2012-01-19 |
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